Early and Late Removal of the Urinary Catheter After Rectum Resection

Comparison of Early and Late Removal of the Urinary Catheter After Low Anterior Resection

It was aimed to investigate the need for urinary retention and recatheterization in the postoperative period by removing the urinary catheter in patients undergoing low anterior resection, in the early or late period.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Colorectal Surgery; Urinary Retention Postoperative
• Intervention / Treatment: Procedure: Procedure: Early removal group; Procedure: Procedure: Late removal group

Detailed Description

Urinary catheter is placed before abdominal surgery to increase visualization during the operation, prevent bladder injury and provide perioperative urine output monitoring. It is especially useful in patients who will undergo low anterior resection, with a high risk of nerve damage and consequent urinary retention and bladder dysfunction. Urinary catheter removal time differs between operations. Traditionally, the urinary catheter is kept in place for 7 days because urinary retention occurs in some patients whose urinary catheter is displaced in the early period. As the urinary catheter retention time increases, the risk of urinary tract infection also increases.

According to the current ERAS protocol, it is recommended to remove the urinary catheter 48 hours after the surgery in patients who have undergone colorectal surgery and are treated with epidural pain management. However, the ERAS protocol is not specific to patients who have undergone low anterior resection, which is the main point of our study and includes all patients who have undergone colorectal surgery. Most authors still believe that prolonged retention of the urinary catheter will prevent urinary retention and long-term bladder dysfunction. In a randomized controlled study (published in 1999) that we encountered during our own literature search, early removal of the urinary catheter was associated with increased urinary retention [2]. In recent studies, some authors have associated the early removal of the urinary catheter with increased urinary retention [3], while others claimed the opposite and reported contradictory results [4]. Advances in laparoscopic techniques have made it possible to visualize the hypogastric and pelvic nerves (nerves associated with urinary functions) during surgery. In addition to these developments, dissections on embryonic planes and tumor reduction with neoadjuvant chemotherapy protect these nerves during surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tevfik Uprak, MD; Phone Number: +905337273328; Email: kuprak@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 3846
    • Recruiting
    • Marmara university Pendik Research and Education Hospital
    • Contact: Tevfik Uprak, MD; Phone Number: 905337273328; Email: kuprak@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who will undergo Low Anterior Resection due to rectal cancer in the Department of General Surgery of our university.
• Competent to consent to participate in trial
• Elective surgery
• ASA classification of 1~3

Exclusion Criteria:

• Patients whose post-treatment status cannot be obtained.

  • Having Bladder surgery before
  • Having a previous prostate surgery.
  • Patient's refusal to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Early group; Patients whose catheters are removed within the first 48 hours after surgery will form the early group.	Procedure: Procedure: Early removal group; Participants assigned this arm will have their urethral catheters removed at 2 days after low anterior resection of the rectum
Other: Late group; Patients whose catheters are removed after the first 48 hours of surgery will form the early group.	Procedure: Procedure: Late removal group; Participants assigned this arm will have their urethral catheters removed after 48.th hours after Low anterior resection of the rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative urinary retention requiring re-catheterisation	Development of acute post-operative urinary retention requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period.	1 day
Postoperative urine culture	Investigate any colonization before discharge in both groups	7 days
Discharge with urinary catheter	Any need for urinary catheter at the time of the discharge	7 days

Collaborators and Investigators

• Sponsor: Marmara University

Publications and helpful links

General Publications

• Duchalais E, Larson DW, Machairas N, Mathis KL, Dozois EJ, Kelley SR. Outcomes of Early Removal of Urinary Catheter Following Rectal Resection for Cancer. Ann Surg Oncol. 2019 Jan;26(1):79-85. doi: 10.1245/s10434-018-6822-x. Epub 2018 Oct 23.
• Xu L, Tao ZY, Lu JY, Zhang GN, Qiu HZ, Wu B, Lin GL, Xu T, Xiao Y. A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial. Trials. 2019 Feb 15;20(1):133. doi: 10.1186/s13063-019-3210-1.
• Yoo BE, Kye BH, Kim HJ, Kim G, Kim JG, Cho HM. Early Removal of the Urinary Catheter After Total or Tumor-Specific Mesorectal Excision for Rectal Cancer Is Safe. Dis Colon Rectum. 2015 Jul;58(7):686-91. doi: 10.1097/DCR.0000000000000386.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: 412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No